MAUDE Adverse Event Report: MEDTECH SA ROSA BRAIN; COMPUTER-ASSISTED SURGICAL DEVICE

Model Number ROSA BRAIN 3.0

Device Problem Unintended Collision (1429)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/21/2019

Event Type  malfunction  

Manufacturer Narrative

The device has not been evaluated yet for investigation purpose.Once the evaluation is performed, a follow-up medwatch report will be submitted. .

Event Description

When performing markers registration, the resident accidentally collided pointer probe in the leksell frame, resulting in shutdown.There is no known impact for the patient.

Event Description

When performing markers registration, the resident accidentally collided pointer probe in the leksell frame, resulting in shutdown.There is no known impact for the patient.

Manufacturer Narrative

It was reported that a shutdown occurred during surgery due to a collision between the pointer probe and the leksell frame.A dhr review and a complaint history review were performed and did not identify any contributory factors to the event.Analysis of data log determined that the cause of the collision is a mismanagement of the vigilance device pedal which is considered as use error.Indeed, the ifu provides the information on how to prevent collisions.

• Brand Name: ROSA BRAIN
• Type of Device: COMPUTER-ASSISTED SURGICAL DEVICE
• Manufacturer (Section D): MEDTECH SA; zac eureka; 900 rue du mas de verchant; montpellier, languedoc-roussillon 34000 ; FR 34000
• MDR Report Key: 8498963
• MDR Text Key: 141453134
• Report Number: 3009185973-2019-00129
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• PMA/PMN Number: K151359
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ROSA BRAIN 3.0
• Device Catalogue Number: ROSA BRAIN
• Device Lot Number: 3.0.0.21
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1